U.S. patent number 7,569,063 [Application Number 11/581,128] was granted by the patent office on 2009-08-04 for instrument for storing and dispensing a surgical fastener.
This patent grant is currently assigned to Sofradim Production SAS. Invention is credited to Pierre Bailly, David Perdreaux, Michel Therin.
United States Patent |
7,569,063 |
Bailly , et al. |
August 4, 2009 |
Instrument for storing and dispensing a surgical fastener
Abstract
The device, designed to be fixed to the distal end of a
fastener-positioning instrument, comprises a plane transverse
distal end, a split first longitudinal channel and a second
longitudinal channel, in which channels the anchoring bar and the
stop bar of a fastener can slide, respectively. The device has a
longitudinal bearing face that defines a half-space. The device
further includes: a cam forming a stop/sliding surface for the
distal end of the stop bar, in order to produce a pivoting movement
of the stop bar; cams for the lateral splaying of the proximal part
of the stop bar; and an escapement cam, allowing the lateral
displacement of the distal part of the stop bar and its
disengagement from the first cam.
Inventors: |
Bailly; Pierre (Caluire,
FR), Therin; Michel (Lyons, FR), Perdreaux;
David (Saint Etienne sur Chalaronne, FR) |
Assignee: |
Sofradim Production SAS
(Trevoux, FR)
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Family
ID: |
39302248 |
Appl.
No.: |
11/581,128 |
Filed: |
October 13, 2006 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20080087703 A1 |
Apr 17, 2008 |
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Current U.S.
Class: |
606/143 |
Current CPC
Class: |
A61B
17/0401 (20130101); A61B 17/064 (20130101); A61B
17/068 (20130101); A61B 2017/0409 (20130101); A61B
2017/0419 (20130101); A61B 2017/0647 (20130101) |
Current International
Class: |
A61B
17/10 (20060101) |
Field of
Search: |
;606/143,139,142
;227/67,68,72 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2 876 020 |
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Apr 2006 |
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FR |
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WO 87/01270 |
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Mar 1987 |
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WO |
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WO 98/51179 |
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Nov 1998 |
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WO |
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WO 99/39645 |
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Dec 1999 |
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WO |
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WO 00/67644 |
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Nov 2000 |
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WO |
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WO 03/075773 |
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Sep 2003 |
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WO |
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Other References
European Search Report from European Patent Application No. EP 06
29 1612 dated Feb. 27, 2007. cited by other.
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Primary Examiner: Ho; (Jackie) Tan-Uyen T.
Assistant Examiner: Lauer; Christina
Attorney, Agent or Firm: Carter, DeLuca, Farrell &
Schmidt, LLP
Claims
The invention claimed is:
1. A device for deploying and ejecting a recumbent I-shaped
surgical fastener, the fastener having an anchoring bar, a stop bar
and a linking strip, the device intended to be positioned adjacent
a distal end of an instrument for storing, dispensing and
positioning fasteners, the device having a longitudinal axis, a
proximal end and a distal end that lies in a first plane
approximately orthogonal to the longitudinal axis and includes a
first longitudinal channel emerging at the proximal and distal ends
of the device, in which the anchoring bar of the fastener can slide
longitudinally up to a point where it is ejected at the distal end
of the device, the first longitudinal channel having a longitudinal
slot intended for passage of the linking strip of the fastener
during the sliding, wherein the device has an approximately
longitudinal bearing face that defines an open half-space not
containing the first longitudinal channel and in that the device
further includes: a second longitudinal channel in which the stop
bar can slide towards the distal end of the device, the second
longitudinal channel lying approximately in the first plane,
emerging at the proximal end of the device and extending into the
open half-space against the bearing face; a first cam that closes
off the distal end of the second longitudinal channel, designed to
form a stop surface for a distal part of the stop bar and to allow
sliding from the distal end of the device in the opposite direction
to the first channel, so as to produce a pivoting movement of the
stop bar; at least one approximately transverse splaying cam,
located proximal to the first cam, capable of cooperating with the
at least one of the linking strip and the stop bar in order to
cause a lateral splaying movement of the proximal part of the stop
bar away from the bearing face; and an approximately transverse
escapement cam, located between the first cam and the at least one
approximately tranverse splaying cam, capable of cooperating with
the distal part of the stop bar in order to allow lateral
displacement of the distal part of the stop bar away from the
bearing face, and its disengagement from the first cam.
2. A device according to claim 1, wherein the first cam generally
lies in a plane orthogonal to the bearing face and is inclined,
going away from the first longitudinal channel, from the proximal
end of the device towards the distal end.
3. A device according to claim 1, wherein the first cam has, as
seen in cross section in a longitudinal plane orthogonal to the
bearing face, a concave shape.
4. A device according to one of claim 1, further comprising two
approximately transverse splaying cams designed to cause two
sequenced lateral splaying movements of a proximal part of the stop
bar.
5. A device according to claim 1, further comprising a longitudinal
rib projecting approximately at right angles from the bearing face
and a proximal face of the longitudinal rib forms a first ramp
constituting at least one approximately transverse splaying
cam.
6. A device according to claim 5, wherein the longitudinal rib has
a proximal part and a distal part which is of greater height than
its proximal part, the proximal face of the distal part of the
longitudinal rib forming a second ramp which, located downstream of
the first ramp, constitutes the approximately transverse escapement
cam.
7. A device according to claim 5, further comprising a cavity
formed in the bearing face, in line with the first longitudinal
channel, upstream of the proximal face of the longitudinal rib, a
distal face of which constitutes a second of the at least one
approximately transverse splaying cam.
8. A device according to claim 1, wherein the first longitudinal
channel has a distal part and a proximal part of larger transverse
dimension than the distal part, a side wall of the proximal part of
the first longitudinal channel forming a ramp over which a distal
end of the anchoring bar of the fastener can slide in order to
cause a lateral displacement of the anchoring bar towards the
distal part of the first channel.
9. A device according to claim 1 wherein the device has an
approximately cylindrical shape, with a diameter less than 6
mm.
10. A device according to claim 9, wherein further comprising a
proximal cylindrical appendage of smaller diameter than the device,
intended to be inserted into the distal end of an instrument for
storing, dispensing and positioning surgical fasteners.
11. A device according to claim 1 wherein the distal end of the
device includes a transverse wall substantially flanking a distal
outlet of the first longitudinal channel.
12. An instrument for storing, dispensing and positioning I-shaped
surgical fasteners, the fasteners having an anchoring bar, a stop
bar and a linking strip, the instrument comprising a gripping means
provided with an actuator that can move on a body of the gripping
means between a pushed-out position and a pushed-in position, an
elongate tubular body in which fasteners are stored longitudinally
one behind another, which elongate tubular body is fixed to the
body of the gripping means, characterized in that it further
includes a device for deploying and ejecting a fastener according
to claim 1, which device is fixed to a distal end of the elongate
tubular body so that the open half-space is located outside the
tubular body.
13. An instrument according to claim 12, further comprising: a
stationary component housed in the elongate tubular body and a
moving component housed in the elongate tubular body so that it can
be moved in longitudinal translation with respect to the stationary
component by means of an advancing rod that can be actuated by the
actuator, the stationary component and moving component being
placed adjacent a longitudinal face and each having a corresponding
notch provided in the longitudinal face, with a pitch corresponding
to the length of the stop bar of the fastener; and a slide placed
between the longitudinal face of the stationary component and
moving component, having an approximately plane main part, a distal
part that bears against a proximal end of the stop bar of the
furthest upstream fastener and, in its proximal end, a first
resilient tongue projecting towards the moving component and a
second resilient tongue projecting towards the stationary
component, each capable of being engaged in the respective
corresponding notch, a geometry of the corresponding notches being
designed so that a displacement of the moving component with
respect to the stationary component towards a distal end of the
instrument causes, thanks to the first resilient tongue engaged in
the corresponding notch of the moving component, a displacement of
the slide in the same direction, until the second resilient tongue
of the slide is engaged in the corresponding notch of the
stationary component, and so that a cooperation between the second
resilient tongue and the corresponding notch of the stationary
component prevents the slide from returning towards a proximal end
of the instrument when the moving component is displaced relative
to the stationary component towards the proximal end of the
instrument.
14. An instrument according to claim 13, wherein the stationary
component and moving component have a form of semicylinders, the
moving component including a radial orifice into which a curved end
of the advancing rod is inserted.
15. An instrument according to claim 12, further comprising,
fixedly housed in a distal part of the elongate tubular body, a
magazine for storing the fasteners, wherein the magazine includes a
first longitudinal housing that receives the anchoring bars of the
fasteners and, contiguously, an ejection rod that can be actuated
by the actuator, a second longitudinal housing that receives the
stop bars of the fasteners, and a third housing, which joins the
first and second longitudinal housings, for passage of the linking
strips.
16. An instrument according to claim 12, wherein the gripping means
comprises: first and second levers that can be moved, by pushing in
the actuator, between an upstream rest position and a downstream
end position, causing a longitudinal displacement in a distal
direction of a rod for ejecting the most downstream fastener out of
the device and the rod for advancing the fasteners in the elongate
tubular body, respectively; a member mounted so as to pivot about a
pin attached to the body of the gripping means, which member
includes a first tooth capable of cooperating with a rack on one of
the first and second levers during displacement of the actuator;
and an elastic return means comprising a first end and a second
end, the first end being connected to a pivoting member and the
second end being connected to the body of the gripping means, the
elastic return means and a profile of the first tooth and of the
rack being designed so that: when the actuator is pushed in as far
as an intermediate pushed-in position, the elastic return means
urges the pivoting member towards a position such that the
cooperation between the first tooth of the pivoting member and the
rack prevents the actuator from returning to the pushed-out
position from the intermediate pushed-in position; and after the
first and second levers have reached their downstream end position,
upon releasing the actuator as far as an intermediate release
position, the elastic return means urges the pivoting member
towards a position such that the cooperation between the tooth of
the pivoting member and the rack prevents the actuator from being
pushed in from the intermediate release position.
17. An instrument according to claim 16, wherein the rack includes
at a distal end, a second tooth of larger size than the first tooth
and in that the pivoting member includes, on a first side
comprising a finger and, on a second side comprising a tab that is
capable of cooperating with a stop attached to the body of the
gripping means when the finger comes into contact with the second
tooth, so that, when the actuator has been pushed in, an elastic
deformation of the tab of the pivoting member in contact with the
stop is necessary in order for the finger to pass beyond said
second tooth.
Description
The present disclosure relates to a device for deploying and
ejecting a recumbent I-shaped surgical fastener, the fastener
comprising an anchoring bar, a stop bar and a linking strip. The
device is configured for attachment at a distal end of an
instrument for storing, dispensing and positioning such
fasteners.
WO 03/075773 already discloses an instrument for dispensing and
positioning surgical fasteners with the aim of fastening the fabric
of a prosthesis to human tissue, for example the abdominal wall of
a patient. In that document, the fasteners are positioned by means
of a hollow, bevelled needle, which passes through the prosthesis
and flesh.
Also disclosed, in document FR 2 876 020, is another instrument for
dispensing and positioning surgical fasteners, in which the needle
is replaced with an ejection guide, the distal end of which is
straight and not bevelled. Penetration of a fastener into flesh is
ensured by the shape of the distal part of the anchoring bar,
namely a conical shape terminating in a hemispherical shape.
At rest the ejection guide is housed in the tubular body of the
instrument and the positioning of the fasteners is accompanied by
the translational movement of the ejection guide towards the distal
end of the instrument, the length of the projecting part of the
ejection guide at the moment of ejection being equal to 3 mm or
less. The fasteners, initially in the form of a recumbent I, are
unfolded inside the ejection guide, therefore inside the tubular
body of the instrument, and it is only once the stop bar is
straightened up that it leaves the tubular body.
Such an instrument may be used by introducing the tubular body into
a trocar. The tendency is to use trocars having the smallest
diameter possible, for example around 5 mm. The diameter of the
tubular body is therefore reduced accordingly. It follows that the
fasteners, which must have dimensions sufficient to exert their
retention function on the prosthesis in human tissue, are forced,
when they are being stored in this tubular body, to be even more
folded-up. Their deployment is therefore more tricky and, in
addition, it cannot take place in the tubular body, the diameter of
which is smaller than the size of an unfolded fastener.
One object of the present disclosure is to provide a device for
deploying and ejecting a recumbent I-shaped surgical fastener,
which allows satisfactory deployment of the fastener even when it
is stored in a small-diameter tubular body.
For this purpose, and according to a first aspect, the disclosure
relates to a device for deploying and ejecting a recumbent I-shaped
surgical fastener. The fastener comprises an anchoring bar, a stop
bar and a linking strip. The device is positioned adjacent a distal
end of the instrument and is intended to be fixed to the distal end
of an instrument for storing, dispensing and positioning such
fasteners, the device having a longitudinal axis and a distal end
that lies in a plane approximately orthogonal to the longitudinal
axis and includes a first longitudinal channel emerging at the
proximal and distal ends of the device, in which the anchoring bar
of a fastener can slide longitudinally up to a point where it is
ejected at the distal end of the device, the first channel having a
longitudinal slot intended for passage of the linking strip of said
fastener during said sliding.
According to a general definition of the disclosure, the device has
an approximately longitudinal bearing face that defines an open
half-space. The device further includes: a second longitudinal
channel in which the stop bar can slide towards the distal end of
the device, the second channel lying approximately in the same
plane as the first channel and the slot of the first channel,
emerging at the proximal end of the device and extending into the
open half-space against the bearing face; a first cam that closes
off the distal end of the second channel and designed to form a
stop surface for the distal end of the stop bar and to allow
sliding from said distal end in the opposite direction to the first
channel so as to produce a pivoting movement of the stop bar; at
least one approximately transverse splaying cam, located proximal
to the first cam, capable of cooperating with the linking strip
and/or the stop bar in order to cause a lateral splaying movement
of the proximal part of the stop bar away from the bearing face;
and an approximately transverse escapement cam, located between the
first cam and the one or more splaying cams, capable of cooperating
with the distal part of the stop bar in order to allow lateral
displacement of the distal part of the stop bar away from the
bearing face, and its disengagement from the first cam.
When the deployment of the ejection device is fixed to the distal
end of the instrument, the open half-space lies outside the tubular
body of this instrument. It is in this half-space that the
deployment of the fastener takes place, which is therefore not
impeded by the tubular body of restricted dimensions.
This arrangement, in combination with the fact that the first cam
is shaped so as to allow the distal end of the stop bar to slide
away from the first channel, allows the stop bar to pass beyond the
diameter of the deployment/ejection device, both downwards (away
from the first channel) and upwards. This was not possible with the
instruments of the prior art, in which there was only a means of
blocking the distal end of the stop bar, which did not allow the
latter to slide downwards--it was therefore necessary for the
tubular body to have a large diameter, especially so as to permit
the stop bar to pivot without the proximal end of the latter being
blocked in this movement by butting against the internal face of
the tubular body.
Moreover, owing to the fact that the distal end of the device lies
in a plane approximately orthogonal to the longitudinal axis, the
device is capable of dispensing the fasteners with minimum
trauma.
The first cam may generally lie in a plane orthogonal to the
bearing face and is inclined, on going away from the first channel,
from the proximal end of the device towards the distal end.
Advantageously, the first cam has, seen in cross section in a
longitudinal plane orthogonal to the bearing face, a concave shape.
It thus forms a gutter that allows the distal end of the stop bar
to be guided during its sliding movement, while preventing it from
escaping.
In one embodiment, the device may comprise two splaying cams
designed to cause two sequenced lateral splaying movements of the
proximal part of the stop bar.
The device may also include a longitudinal rib projecting
approximately at right angles from the bearing face. The proximal
face of said rib forms a first ramp constituting a splaying cam.
Furthermore, the rib may have a distal part of greater height than
its proximal part, the proximal face of the distal part of the rib
forming a second ramp which, located distal of the first ramp,
constitutes the escapement cam.
In one embodiment, the device includes a cavity formed in the
bearing face, in line with the first channel, proximal of the
proximal face of the rib, the distal face of which constitutes a
subsequent splaying cam.
Moreover, the first channel may have a proximal part of larger
transverse dimension than the distal part, a side wall of the
proximal part of the first channel forming a ramp over which the
distal end of the anchoring bar of a fastener can slide in order to
cause the lateral displacement of said anchoring bar towards the
distal part of the first channel.
In embodiments, the device may have an approximately cylindrical
shape, with a diameter less than 6 mm. It may further include a
proximal cylindrical appendage of smaller diameter, intended to be
inserted into the distal end part of an instrument for storing,
dispensing and positioning surgical fasteners.
In one embodiment, the distal end of the device includes a
transverse wall substantially flanking the distal outlet of the
first channel. The material added by the presence of this
transverse wall provides further protection of the device and
minimizes the thrust of the distal end of the device against human
tissue when the fastener is being positioned.
According to a second aspect, the disclosure relates to an
instrument for storing, dispensing and positioning recumbent
I-shaped surgical fasteners. The fasteners include an anchoring
rod, a stop bar and a linking strip. The instrument includes a
gripping means provided with an actuator that can move on a body
between a pushed-out position and a pushed-in position. The
instrument further includes an elongate tubular body in which
fasteners are stored longitudinally one behind another. The tubular
body is fixed to the body of the gripping means and further
includes a device for deploying and ejecting a fastener as
described above. The device is fixed to the distal end of the
tubular body so that the open half-space is located outside the
tubular body.
In one embodiment the instrument includes: a stationary component
housed in the tubular body and a moving component housed in the
tubular body so that it can be moved in longitudinal translation
with respect to the stationary component by means of an advancing
rod that can be actuated by the actuator. The stationary and moving
components are positioned along a longitudinal face and each having
notches provided in said longitudinal face, with a pitch
corresponding to the length of the stop bar of a fastener; and a
slide placed between the longitudinal faces of the stationary and
moving components, having an approximately planar main part, a
distal part that bears against the proximal end of the stop bar of
the proximal most fastener and, in its proximal part, a first
resilient tongue projecting towards the moving component and a
second resilient tongue projecting towards the stationary
component, each capable of being engaged in a corresponding notch.
The geometry of the notches is designed so that the displacement of
the moving component with respect to the stationary component
towards the distal end of the instrument causes, by means of the
first tongue engaged in a notch of the moving component, the
displacement of the slide in the same direction, until the second
tongue of the slide is engaged in a notch of the stationary
component. The cooperation between the second tongue and a notch of
the stationary component prevents the slide from returning towards
the proximal end of the instrument when the moving component is
displaced relative to the stationary component towards the proximal
end of the instrument.
The stationary and moving components may have the form of
semicylinders, the moving component including a radial orifice into
which the curved end of the advancing rod is inserted.
According to one embodiment, the instrument includes a magazine for
storing the fasteners. The magazine includes a first longitudinal
housing that receives the aligned anchoring bars of the fasteners
and, contiguously, an ejection rod that can be actuated by the
actuator. The magazine further includes a second longitudinal
housing that receives the aligned stop bars of the fasteners, and a
third housing, which joins the first and second housings, is
configured for passage of the linking strips.
The gripping means may include: first and second levers that can be
moved, by pushing in the actuator, between a proximal rest position
and a distal end position. Movement to the end position causes
longitudinal displacement in the distal direction of a rod for
ejecting the distalmost fastener out of the deployment/ejection
device; and of a rod for advancing the fasteners in the tubular
body, respectively; a member mounted so as to pivot about a pin
attached to the body of the gripping means, which member includes a
tooth capable of cooperating with a rack formed on one of the
levers during displacement of the actuator; and a flexible return
means, one end of which is connected to the pivoting member and the
other end of which is connected to the body of the gripping means.
The elastic return means and the profile of the tooth and the rack
being designed so that: when the actuator is pushed in as far as an
intermediate pushed-in position, the elastic return means urges the
pivoting member towards a position such that the cooperation
between the tooth of the pivoting member and the rack of the lever
prevents the actuator from returning to the pushed-out position
from said intermediate pushed-in position; and after the levers
have reached their distalmost end position, upon releasing the
actuator as far as an intermediate release position, the flexible
return means urges the pivoting member towards a position such that
the cooperation between the tooth of the pivoting member and the
rack of the lever prevents the actuator from being pushed in from
said intermediate release position.
A double non-return system may thus advantageously be obtained.
Advantageously, the rack of the lever includes, at its distal end,
a tooth of larger size and the pivoting member includes, a finger
on one side, and a tab on the other side. The rack cooperates with
a stop attached to the body of the gripping means when the finger
comes into contact with the larger tooth. Thus when the actuator
has been pushed in the tab of the pivoting member in contact with
the stop must flex in order for the finger to pass beyond the
larger tooth. When the actuator is pushed in, the user therefore
receives a tactile indication that he has reached the fully
pushed-in position of the actuator, and therefore that the fastener
has been suitably ejected.
The present disclosure also relates to a recumbent I-shaped
surgical fastener having an anchoring bar, a stop bar and a linking
strip. The distal part of the anchoring bar has approximately the
shape of a truncated cone with the external slope of the cone being
more accentuated than the internal slope turned towards the stop
bar.
The fastener is deployed from an internal storage position, in
which it has a recumbent "I" shape, to an operating position, in
which it tends towards an upright "I" configuration. The
accentuation of the external slope of the cone allows the anchoring
bar to pivot more naturally towards the stop bar when the fastener
is being deployed in tissue.
The distal end of the device has a hemispherical shape. Thus, the
fastener penetrates more easily into tissue during its
installation.
One embodiment of the disclosure will now be described with
reference to the appended figures, in which:
FIG. 1 is a side view of an instrument for storing, dispensing and
positioning surgical fasteners;
FIG. 2 is a side view of a recumbent I-shaped surgical fastener in
the storage position;
FIGS. 3 and 4 are perspective views, from the rear and front
respectively, of a device for deploying and ejecting a surgical
fastener;
FIG. 5 is a sectional view of the deployment/ejection device, in a
longitudinal plane;
FIGS. 6 to 15 illustrate successive steps in the deployment and
ejection of a fastener;
FIG. 16 is a side view showing the mechanism of the instrument,
housed inside the gripping means;
FIG. 17 is a perspective view of the slide in the tubular body for
advancing the fasteners;
FIG. 18 is a partial schematic view of a series of fasteners that
are stored in a magazine, and of the distal end of the slide of
FIG. 17;
FIG. 19 is a partial cross-sectional view of the tubular body in
the region that receives the magazine;
FIGS. 20 to 22 are schematic representations in a lateral sectional
view of the fastener-advancing system;
FIGS. 23 and 24 are detailed views of the inside of the gripping
means, showing the non-return system of the actuator;
FIGS. 25 to 27 are detailed views of the inside of the gripping
means, showing the system for indicating the end of push-in travel
of the actuator;
FIG. 28 is a perspective view of an alternative embodiment of the
deployment/ejection device; and
FIG. 29 is a side view of another embodiment of a fastener intended
to be ejected and deployed by means of the deployment/ejection
device.
The instrument 1 shown in FIG. 1 is designed to dispense fasteners
A which have, as shown in FIG. 2, the general shape of a recumbent
"I" and are composed of two parallel bars, namely an anchoring bar
2 and a stop bar 3, joined together by a linking strip 4. The
fastener A is made of plastic, especially a biocompatible and
preferably bioresorbable material.
The distal part 2a of the anchoring bar 2 has a conical shape. This
distal part 2a may include a notch 2b projecting towards the stop
bar 3 in order to protect the anchoring bar 2/linking strip 4
intersection, which is stressed at the moment when the fastener A
is ejected and positioned. Furthermore, the distal end 2c of the
anchoring bar 2 has a hemispherical shape.
The term "proximal" relates to a location closer to the user of the
instrument 1, while the term "distal" relates to a location further
from the user.
The stop bar 3 has a distal end 3a and a proximal end 3b, and has a
length L.
The linking strip 4 is joined to the anchoring bar 2, approximately
at the center of the latter, and is joined to the stop bar 3 in a
region close to the center of the stop bar 3, but slightly offset
towards its proximal end 3b. In one embodiment, the length L of the
anchoring bar may measure 6.5 mm and the anchoring bar/linking
strip join is offset by about 0.5 mm with respect to the center of
the anchoring bar, towards the distal end of the anchoring bar.
The proximal part, or alternatively the distal part, of the stop
bar 3 is defined as that part of the stop bar 3 which is located
between its proximal end 3b, or alternatively its distal end 3a,
and the linking region between the stop bar 3 and the linking strip
4.
In the storage position in the instrument 1, the fastener A is
folded so that the linking strip 4 has two curved regions (in the
vicinity of its points of attachment to the anchoring bar 2 and the
stop bar 3), and a central zone approximately parallel to the bars
2, 3. In this position, illustrated in FIG. 2, the height H of the
fastener may be about 5 mm or less. In embodiments, the height of
the fastener is no more than 4 mm.
As shown in FIG. 1, the instrument 1 includes a gripping means B to
which a tubular body C having a longitudinal axis is fixed. A
socket D surrounds the junction region between these two elements.
From its proximal end, the tubular body C includes, as will be seen
later, a first zone C1 containing a step-by-step system for
advancing the fasteners A followed by a second zone C2 in which the
fasteners A are stored.
Fixedly mounted on the distal end of the tubular body C is a device
5 for deploying and ejecting the fasteners A, said device
projecting beyond the distal end of the tubular body C.
The longitudinal mid-plane of the instrument 1 is defined as the
plane passing through the axis of the tubular body C and dividing
the gripping means B into two approximately identical parts
(corresponding to the plane in which the gripping means B is shown
in FIG. 16). The term "transverse" denotes a direction generally
perpendicular to this plane, or a plane orthogonal to the
longitudinal axis of the tubular body C.
The deployment/ejection device 5 will now be described with
reference to FIGS. 3 to 5.
The device 5 has an approximately cylindrical shape, with a
diameter of about 5 mm or less. In the example shown, it is formed
from a single metal component. In one embodiment the device may be
made of plastic and/or formed from several components.
The proximal part of the device 5 forms a cylindrical appendage 6
intended to be introduced into the tubular body C. The distal part
7 of the device 5 has a larger diameter, approximately identical to
the outside diameter of the tubular body C, and thus defines a
shoulder 8 that butts against the distal end of this body C.
The distal part 7 has the form of a semicylinder bounded by a
bearing face 76 which, in the position in which the device 5 is
fitted onto the instrument 1, lies generally in the longitudinal
mid-plane of the instrument. Thus defined is an open
half-space--except upstream--which allows the fastener A to be
satisfactorily deployed. The distal end 9 of the device 5 is
approximately planar and orthogonal to the longitudinal axis. This
distal end 9 of the device 5 may be slightly domed, provided that
its mean plane is generally orthogonal to the longitudinal axis of
the device 5.
The device 5 includes a first longitudinal channel 10 offset with
respect to the longitudinal axis of the device 5. For the sake of
simplifying the description, it will be considered hereafter that
the first channel 10 is located in the top of the device 5,
recognizing that this device 5, once fitted onto the instrument 1,
may adopt various positions in space during use.
In the proximal part of the device 5, the first channel 10 has a
larger cross section, for reasons that will be explained later. As
shown in FIG. 5, which is a sectional view in a plane passing
through the longitudinal axis of the device and orthogonal to the
longitudinal mid-plane, the junction zone between the proximal and
distal parts of the first channel 10 forms a ramp 12 inclined from
the proximal end towards the distal end, and towards the axis of
the cylindrical distal part of the first channel 10.
The lower zone of the distal part 7 of the device 5 has a shorter
length than the first channel 10. This lower zone includes a
longitudinal rib 13, lying below the slot 11, substantially along
the longitudinal axis of the device 5 and extending substantially
from the middle of the distal part 7 right to the distal end of the
lower zone. The rib 13 includes a proximal part 14, the proximal
face 15 of which forms a ramp a higher distal part 16 of the rib 13
has proximal face 17 which also forms a ramp.
A protuberance 18 on the distal part 16 of the rib 13 extends
downwards and has a triangular shape in side view. A proximal face
19 of protuberance 18 is orthogonal to the longitudinal mid-plane
and inclined downwards from the proximal end of the device 5
towards the distal end 9. In addition, this proximal face 19 has a
concave shape, seen in section in a longitudinal plane orthogonal
to the longitudinal mid-plane.
The device 5 further includes a second longitudinal channel 20,
offset downwards with respect to the longitudinal axis of the
device 5. In the distal part of the device 5, the second channel 20
is opened laterally and defined by a zone 21 set back with respect
to the longitudinal mid-plane lying beneath the rib 13. In the
proximal part of the device 5, the second channel 20 is
approximately cylindrical and joined to the first channel 10 by a
longitudinal housing 22 of downwardly elongate cross section.
The device 5 includes a cavity 23 provided in the wall 24 of the
first channel 10, in the distal part 7 of the device 5, upstream of
the proximal face 15 of the rib 13 and close to the shoulder 8. The
cavity 23 has a distal face 25 generally orthogonal to the
longitudinal mid-plane.
The description now refers to FIGS. 6 to 15 which show the various
phases resulting in the deployment and ejection of a fastener A out
of the instrument 1 by means of the device 5, with a view to fixing
a prosthesis 26 to human tissue 27.
Referring now to FIGS. 5 to 15 the fasteners A are stored in the
tubular body C one behind another with the anchoring bars 2 lying
approximately along the axis of the first channel 10 and the stop
bars 3 along the axis of the second channel 20 (see FIGS. 5 and
18).
As illustrated in FIG. 5, while the fasteners A are being advanced
towards the distal end 9 of the device 5, the end 2c of the
anchoring bar 2 of the fastener A furthest downstream butts against
the ramp 12 which slides over the latter, thus causing the lateral
displacement of said anchoring bar 2 towards the distal part of the
first channel 10. The anchoring bar 2 is then pushed towards the
distal end 9 of the device 5, in a longitudinal sliding movement in
the first channel 10, during which the linking strip 4 slides in
the slot 11 and the stop bar 3 is made to slide in the second
channel 20.
When the distal end 3a of the stop bar butts against the proximal
face 19 of the protuberance 18, which forms a first cam surface
(FIG. 6), this distal end 3a slides downwards against the proximal
face 19, being guided by the shape of the latter. This pivots the
stop bar (FIG. 7) which begins to straighten, while the anchoring
bar 2 starts to project from the device 5.
The junction between the linking strip 4 and the stop bar 3 is then
in contact with the proximal face 15 of the rib 13, forming a
second cam 15 (FIG. 8). Second cam 15 causes a first lateral
splaying movement of the proximal part of the stop bar 3, as shown
in top view in FIG. 9.
The proximal part of the stop bar 3 then comes into contact with
the cavity 23 (FIG. 10). As the sliding of the anchoring bar 2
continues, the distal part of the stop bar 3 continues to slide
downwards against the proximal face 19. The angle of pivoting of
the stop bar 3 progressively increases and the proximal part of the
stop bar 3 cooperates with the distal face 25 of the cavity 23,
forming a third cam 25. As a result, the lateral splaying of the
proximal part of the stop bar 3 increases (FIG. 11). This lateral
splaying allows the stop bar 3 to avoid the lower face of the first
channel 10, which would prevent the continuation of the pivoting
movement.
Next, the proximal part of the stop bar 3 slides against the wall
24 of the first channel 10 until the distal part of the stop bar 3
comes into contact with the proximal face 17 of the distal part 16
of the rib 13, forming a fourth cam 17 (FIG. 12). This movement
results in the lateral displacement of the distal part of the stop
bar 3, which escapes from the proximal face 19. The stop bar 3 is
then approximately upright (FIG. 13). The continuation of the
thrusting movement of the anchoring bar 2 results in it being
completely ejected from the device 5 (FIG. 14) and then pivoted, at
least through an angle of at least 30.degree. with the linking
strip 4 and preferably an angle ranging up to 90.degree. with this
linking strip 4. Preferably, the anchoring bar 2 pivots until it is
approximately parallel to the upright stop bar 3, which is pressed
against the prosthesis 26, the linking strip 4 then being
approximately perpendicular to the two bars 2, 3 and the fastener A
adopting an upright "I" configuration. In this position (FIG. 15),
the fastener A holds the prosthesis 26 against the human tissue
27.
The instrument 1 will now be described in greater detail.
As illustrated in FIG. 16, the gripping means B includes a body 28,
made in two symmetrical parts assembled by force-fitting them or by
means of rivets or screws, and an actuator 29 mounted so as to move
on the body 28 in an articulated fashion about a transverse pin 30
of the body 28, between a pushed-in position and a pushed-out
position. A spring 31 urges the actuator 29 towards its pushed-out
position.
Housed in the body 29 are the following: a first control lever 32
articulated to a transverse pin 33 of the body 28, the upper part
of said control lever 32 including two projections 34 separated
laterally from each other (only one of them being visible in FIG.
16); and a second control lever 35 articulated to a transverse pin
36, housed between the two projections 34 of the first lever
32.
The first lever 32 has a circularly arcuate lower end provided with
rack 37 and, in its distal part, with a larger tooth 38. These
projections 34 have a cam-shaped distal face 39. Furthermore, the
first lever 32 includes, in the central part, a projection 40
capable of cooperating with a transverse lug 41 provided on the
second lever 35. The latter includes a cavity, the bottom of which
forms a transverse cam 42.
The body 28 of the gripping means B also contains a pivoting member
43 articulated to a transverse pin 44 of the body 28. This pivoting
member 43 includes a tooth 45a (visible in FIGS. 23 and 24) capable
of cooperating with the rack 37 of the first lever 32, a finger 45,
larger than the tooth 45a, and a tab 46 projecting away from the
finger 45. A spring 47 links the pivoting member 43 to a transverse
pin 48 of the body 28.
The gripping means B is completed, inside the socket D, with a
cylindrical ferrule 49 in which, inside a spacer 50, a piston 51 is
fitted. The piston 51 has a thinner proximal end part 52,
introduced between the two projections 34 of the first lever 32
and, on either side of the proximal end part 52 and distal thereof,
two curve surfaces 53 that can cooperate with the cam 39 of the
projections 34.
An ejection rod 54 is fixed (for example welded) to the distal end
of the piston 51, near its periphery. This rod 54 extends
longitudinally, approximately as far as the distal end of the
tubular body C. Moreover, the piston 51 has an approximately
central longitudinal bore in which an advancing rod 55 can slide.
The advancing rod 55 has a proximal end that can cooperate with the
cam 42 of the second lever 35 and a curved distal end 56, located
in the zone C1 of the tubular body C.
The tubular body C includes a hollow metal envelope 57 (cf. FIG.
19) in which various elements are housed.
Fixedly mounted in the second zone C2 of the tubular body C is a
magazine 58 for storing the fasteners A. As illustrated in FIGS. 18
and 19, this magazine 58 comprises a first longitudinal housing 59
that receives the aligned anchoring bars 2 of the fasteners A and,
contiguously, the ejection rod 54, a second longitudinal housing 60
that receives the aligned stop bars 3 of the fasteners A, and a
third housing 61, which joins the first and second housings 59, 60,
for passage of the linking strips 4. These housings 59, 60 and 61
are placed in alignment with the channels 10, 20 and with the
housing 22 (cf. FIG. 3) that are provided in the device 5. It
should be noted that, in FIG. 18, the ejection rod 54 and the
magazine 58 have been truncated in their proximal part in order to
make it easier to understand the figure, all the fasteners A being
in fact housed in the magazine 58. The magazine 58 may be made in
several sections joined together longitudinally.
The first zone C1 of the tubular body C contains a step-by-step
advancing system for the fasteners A, which system will now be
described with reference to FIGS. 17 to 22.
Component 62 is fixed in the envelope 57 of the tubular body C and
is stationary relative to the tubular body C. Component 63, which
can move relative to the stationary component 62 is also positioned
in the envelope 57. Both these components having the shape of
semicylinders superposed along their longitudinal face (FIG.
20).
Provided in the longitudinal face of each of the components 62, 63
are notches 64, arranged with a pitch P approximately equal to the
length L of the stop bar 3 of a fastener A. Each notch 64 has an
upright transverse proximal edge 65 and a distal edge 66 inclined
to the longitudinal axis of the tubular body C towards the
periphery of the latter, upon moving away from the distal end of
the tubular body C towards this proximal end.
The stationary component 62 has a proximal cylindrical part 67 that
defines a transverse stop surface 68. The moving component 63
includes, near its proximal end, a radial orifice 69 into which the
curved end 56 of the advancing rod 55 is inserted. In addition, a
channel (not shown) is provided in the moving component 63 and in
the proximal cylindrical part 67 of the stationary component 62, in
order to house the ejection rod 54.
Placed between the longitudinal faces of the stationary component
62 and the moving component 63 is a slide 70, shown in FIG. 17. The
slide 70 comprises an approximately planar main part 71, a wider
distal part 72 and, in its proximal part, first and second
splayed-apart resilient tongues 73, 74. The slide 70 is for example
formed from a metal sheet, cut and then folded onto itself, which
may be bonded at the main 71 and distal 72 parts, but not at the
tongue 73, 74, which are curved away from each other.
Initially, before the first use of the instrument 1, the slide 70
is mounted such that the first tongue 73, projecting towards the
moving component 63, is engaged in the proximal notch 64 of
component 63, and the second tongue 74, projecting towards the
stationary component 62, is engaged in the proximal notch 64 of
component 62. The moving component 63 is in contact with the
transverse stop surface 68 of the stationary component 62, and the
notches 64 of the components 62, 63 face each other in pairs. The
distal part 72 of the slide 70 is engaged in the third housing 61
(FIG. 19), bearing against the proximal end 3b of the stop bar 3 of
the proximal most fastener A.
The operation of the instrument 1 will now be described.
When a user presses on the actuator 29, it causes the first lever
32 to start to pivot, which, through the cooperation between the
projection 40 and the lug 41, results in the second lever 35
pivoting. Through the cooperation between the proximal end of the
advancing rod 55 and the cam 42 of the second lever 35, the
advancing rod 55 is displaced longitudinally downwards, taking with
it the moving component 63, which slides longitudinally relative to
the stationary component 62 (FIG. 21). The mechanism is designed so
that this displacement corresponds to the pitch P, and therefore to
the length L of the stop bar 3 of a fastener A. This value is, for
example, about 7 mm.
During this movement, the proximal edge 65 of the proximal notch 64
of the moving component 63 pushes the first tongue 73 downstream.
The slide 70 is therefore displaced downstream (the second tongue
74 deforming elastically in order to come into the plane of the
main part 71 of the slide 70) and, at the end of the movement, the
second tongue 74 is housed in the notch 64 located immediately
distal of the proximal notch of the stationary component 62.
The distal part 72 of the slide 70 has therefore pushed the train
of fasteners A via the stop bars 3, distally, by the distance P,
and therefore the distance L. Consequently, the distalmost fastener
A has been displaced in the deployment and ejection device 5, and
its anchoring bar 2 has slid over the ramp 12 so as to come into
alignment with the ejection rod 54 (FIG. 5).
When the user continues to push in the actuator 29, the second
lever 35 remains immobile, as therefore do the advancing rod 55,
the moving component 63, the slide 70 and the fasteners A (with the
exception of the most downstream one). However, the pivoting of the
first lever 32 continues, which, Continued actuation of the
actuator 29, through the cooperation between the cams 39 of the
projections 34 and the curve surfaces 53 of the piston 51, results
in the ejection rod 54 sliding longitudinally downstream. It should
be noted that the sliding of the rods 54, 55 is not the same, this
being made possible by the fact that the advancing rod 55 slides in
the piston 51 to which the ejection rod 54 is fixed.
The distal end of the ejection rod 54 then pushes the anchoring bar
2 of the fastener A located furthest downstream into the
deployment/ejection device 5. Via the steps described above (FIGS.
6 to 15), the anchoring bar 2 is ejected into the tissue 27, while
the stop bar 3 pivots and the fastener A is deployed. This
deployment takes place in the open half-space of the device 5, and
therefore outside the tubular body C. The longitudinal travel of
the ejection rod 54 is, for example, about 24 mm.
The user can then release the actuator 29. Various elastic return
means (not shown) allow the rods 54, 55 to return to their initial
positions, awaiting the next time the actuator 29 is pushed in.
When the advancing rod 55 slides proximally, it brings the moving
component 63 back against the transverse stop surface 68 of the
stationary component 62. However the second tongue 74, in abutment
against the proximal edge 65 of the notch 64 of the stationary
component 62, prevents the slide 70 from returning further
proximal. In FIG. 22, the slide 70 has therefore advanced by one
pitch P distally relative to FIG. 20, and it will therefore be able
to advance the train of fasteners A distally by one pitch the next
time the actuator 29 is pushed in.
Finally, the double non-return system with which the gripping means
B is provided will be described with reference to FIGS. 16 and 23
to 27.
Before use, the pivoting member 43 is in the neutral position, as
shown in FIG. 16.
When the actuator 29 is pushed in as far as an intermediate
position, wherein the tooth 45a of the pivoting member 43
cooperates with the rack 37 of the first lever 32, the spring 47
urges the pivoting member 43 (indicated by the arrow F in FIG. 23)
in such a way that the tooth 45a, engaged in the rack 37, prevents
the actuator 29 from returning to the pushed-out position from said
intermediate position. Thus, the user is forced to continue to
press on the actuator in order for the procedure of advancing,
deploying and ejecting the fastener A to be completely
finished.
Towards the end of the movement of pushing in the actuator 29, the
finger 45 of the pivoting member 43 comes into contact with the
larger tooth 38 (FIG. 25). This results in the pivoting member 43
pivoting about its pin 44 until the tab 46 comes into contact with
a stop 75 integral with the body 28 of the gripping means B (FIG.
26). An elastic deformation of the tab 46 of the pivoting member 43
in contact with the stop 75 is required for the finger 45 to pass
beyond the larger tooth 38 after the actuator has been pushed in
(FIG. 27). This constitutes a hard point felt by the user, who can
therefore know whether or not the end of travel has been reached
and, consequently, whether the fastener A has been correctly
ejected. In addition, when the finger 45 passes beyond the larger
tooth 38, a sudden pivoting of the first lever 32 takes place, and
therefore a sudden advance of the ejection rod 54. This impact is
transmitted to the distalmost fastener A which makes it easier to
eject and pivot it.
At this step, the pivoting member 43 returns to a neutral position,
similar to that shown in FIG. 16, but this time beyond rack 37.
Next, when the actuator 29 is released as far as an intermediate
position, the spring 47 urges the pivoting member 43 (indicated by
the arrow F' in FIG. 24) in such a way that the tooth 45a, engaged
in the rack 37, prevents the actuator 29 from being pushed in from
said intermediate position. Thus, the user cannot start a new cycle
(advance of the train of fasteners and ejection of the distalmost
fastener) until the mechanism has been returned to its rest
position. This prevents the mechanism from becoming blocked and
guarantees successful ejection of each of the fasteners A.
Another embodiment of the fastener A' is shown in FIG. 29. Fastener
A' has no notch. Fastener A' of FIG. 29 has the general shape of a
recumbent "I" in the storage state. The references denoting the
same elements as in FIG. 2 have been preserved. The fastener A'
comprises an anchoring bar 2 joined to a stop bar 3 via a linking
strip 4. The fastener A' may be made of biocompatible and
bioresorbable plastic.
The end 2c of the anchoring bar 2 has a hemispherical shape and the
distal part 2a of the anchoring bar 2 has approximately the shape
of a truncated cone, the external slope 2d of the cone, turned
towards the outside of the fastener, being however more accentuated
than the internal slope 2e, turned towards the stop bar 3. This
accentuation of the external slope 2d of the cone allows the
anchoring bar 2 of the fastener A' to pivot more naturally towards
the stop bar 3 when the fastener is being positioned in tissue, as
shown in FIGS. 13 to 15--pivoting of the fastener A' is thus
favored and its deployment towards an upright "I" configuration is
thus facilitated.
In the distal part of the device 5, the first channel 10 is
approximately cylindrical and has a longitudinal slot 11 opened
downwards. This first channel 10 emerges at its distal end near the
distal end 9 of the device 5. FIG. 28 shows an alternative
embodiment of the device 5 of FIG. 4, in which the distal end 9 of
the device 5 includes a transverse wall 9a substantially flanking
the distal outlet of the first channel 10. The material added by
the presence of this transverse wall 9a provides further protection
of the device 5 and minimizes the thrust of the distal end 9 of the
device 5 against human tissue when the fastener A is being
positioned, for example during the steps shown in FIGS. 6 and
7.
The invention therefore provides a definite improvement over the
prior art, by providing a device for deploying and ejecting
surgical fasteners and an instrument for storing, dispensing and
positioning them that can be used in small-diameter trocars, while
still guaranteeing satisfactory deployment of the fasteners and,
consequently, very good retention of a prosthesis against human
flesh.
The invention is not limited to the embodiment described above by
way of example, but on the contrary it encompasses all alternative
embodiments thereof.
* * * * *